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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04552574
Other study ID # CBNUH202006021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 19, 2020
Est. completion date December 31, 2021

Study information

Verified date September 2020
Source Chungbuk National University Hospital
Contact Yonghwan Kim, MD
Phone 82-43-269-6060
Email airsantajin@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigate whether HMR(Home meal replacement)-type omega-3-balanced-diet can improve clinical laboratory values related to chronic metabolic diseases through reducing lipids and chronic inflammation, and can prevent muscle loss.


Description:

Korea is entering an post-aged society with an increase in single-person households, and as the average life expectancy increases, the increase in the population exposed to chronic metabolic diseases requires basic dietary solutions for life seeking physical, mental and social well-being. As a result of a survey conducted by the Korean Health Insurance Corporation (2010), medical expenses for chronic metabolic diseases were estimated at 15,233.8 billion won, with 54.3% of adults with chronic diseases, 68.7% in their 50s, 83.7% in their 60s, and 91.3% in their 70s or older. This trend continues to increase, resulting in an increasing social burden. Our researchers focused on functional lipids which provide specific health benefits when ingested to prevent these chronic diseases. Omega 3 is an essential fatty acid that can not be synthesized in the body, maintaining the structure of cells in the human body, helping smooth metabolism. It also inhibits the aggregation of platelets and lowers the risk of coronary artery or cardiovascular disease by lowering the level of neutrality, it has been reported to have an inflammatory mitigation effect. Omega 6 has been reported to cause increased inflammation and ulticaria, asthma, cardiovascular disease side effects when intake is increased. In this context, the recommended ratio of omega 3 and omega 6 is reported to be within 1:4.

A diet of which omega-3 to omega-6 ratio is below 1:4 was developed by Agricultural entity Green Grass Co., Ltd. for prevention of sarcopenia and chronic metabolic disease.

Subjects assigned to the test group receive a total of 4 weeks HMR medifood and consume a regular diet for the next four weeks after having a wash-out period for a total of two weeks. On the other hand, subjects assigned to the control group would be able to consume a regular diet for the first four weeks and take HMR medifood for the next four weeks after having a two-week wash-out period.


Recruitment information / eligibility

Status Recruiting
Enrollment 76
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria:

- BMI(Body mass index): 25-40 kg/m2

- Circumference of waist: =90 cm in men and =85 cm in women

- sBP(systolic Blood pressure): 100-180mmHg

- dBP(diastolic Blood pressure): 70-110mmHg

- Alcohol consumption: =14 glasses/week in men and =7 glasses in women

Exclusion Criteria:

- Ongoing administration of antihypertensive drugs

- Past medical history of diabetes, dyslipidemia, cardiocerebrovascular disease, or ongoing administration of drugs related to the aforementioned diseases

- Allergies to dairy products or other foods

- Smokers

- Subjects who intend to lose weight in-between during the period of clinical trial

- Abnormal at the screening blood test(AST(Aspartate transaminase), ALT(Alanine transaminase)>100 IU/L, TG(triglyceride)>400 mg/dL, total cholesterol>300 mg/dL, LDL(Low-density lipoprotein)-cholesterol>190 mg, WBC>10000/µL or <1500/µL, hsCRP>5 mg/L)

- Pregnant or breastfeeding women

Study Design


Intervention

Dietary Supplement:
HMR(Home meal replacement)-type omega-3-balanced diet
A diet of which omega-3 to omega-6 ratio is below 1:4 was developed by Agricultural entity Green Grass Co., Ltd.. A committee of experts that is composed of several university professors in authorities of IPET(Institute of Planning and Evaluation for Technology in food, agriculture and forestry) also participated in the development of this diet.

Locations

Country Name City State
Korea, Republic of Chungbuk National University Hospital Cheongju Chungcheongbuk-do

Sponsors (1)

Lead Sponsor Collaborator
Chungbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lipids LDL(Low-density lipoprotein)-cholesterol and HDL(High-density lipoprotein)-cholesterol 4 weeks
Primary triglyceride Lipids 4 weeks
Primary Muscle mass SLM (Soft lean mass) 4 weeks
Secondary WBC (White blood cell) count Inflammation 4 weeks
Secondary hsCRP (high-sensitivity C-reactive protein) Inflammation 4 weeks
Secondary Balance between omega-3 fatty acids and omega-6 fatty acids Omega-3 fatty acids to omega-6 fatty acids ratio 4 weeks
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